FDA: Ista eye drug - no serious side effects

June 24, 2009 1:15:21 PM PDT
Federal health scientists say an anti-itching drug from eye care company Ista Pharmaceuticals did not show any serious side effects in testing on patients. Ista is asking the Food and Drug Administration to approve its formula Bepreve to relieve itchiness caused by seasonal allergies.

In documents posted online, the FDA says no patients tested with the drug experienced a dangerous side effect. Of the patients who did have a side effect, half had a decreased sense of taste, known as dysgeusia. That side effect was classified as mild or moderate.

FDA plans to ask a panel of experts next week whether Bepreve is safe and effective for allergic conjunctivitis. The agency is not required to follow the group's advice, though it usually does.


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